DRUG DELIVERY DEVICES WITH DRUG-PERMEABLE COMPONENT AND METHODS

• US 20160339217A1
• Filed: 08/08/2016
• Published: 11/24/2016
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Taris Biomedical LLC (Johnson & Johnson)
• Original Assignee: Taris Biomedical LLC (Johnson & Johnson)
• Inventors: Lee, Heejin, Daniel, Karen, Sansone, Matthew
• Granted Patent: US 10,286,199 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/216 of acids having aromatic rings, e.g. benactizyne, clofibrate
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 31/407 condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
• CPC Class Codes: A61K 31/438 The ring being spiro-condensed with carbocyclic or heterocyclic ring systems
• CPC Class Codes: A61K 31/46 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
• CPC Class Codes: A61K 31/555 containing heavy metals, e.g. hemin, hematin, melarsoprol
• CPC Class Codes: A61K 31/7068 having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
• CPC Class Codes: A61K 33/243 Platinum; Compounds thereof
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 2210/1085 Bladder
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 31/007 Injectors for solid bodies, e.g. suppositories

Abstract

Implantable drug delivery devices include a housing having a closed drug reservoir lumen bounded by a first wall structure and a hydrophilic second wall structure, and a drug contained in the drug reservoir lumen, wherein the first wall structure is impermeable to the drug and the second wall structure is permeable to the drug. Methods of providing controlled release of drug to a patient include deploying a drug delivery device in the patient releasing a drug from the drug reservoir lumen via diffusion through the second wall structure.

Claims

1. A drug delivery device comprising:

a housing having a closed drug reservoir lumen bounded by a first wall structure and a hydrophilic second wall structure; and

a drug contained in the drug reservoir lumen,

wherein the first wall structure is impermeable to the drug, and the second wall structure is permeable to the drug, and

wherein the first wall structure and the second wall structure are adjacent one another and together form a cylindrical tube.

2. The device of claim 1, wherein the device is configured for intravesical insertion and retention.

3. The device of claim 2, wherein the device is elastically deformable between a relatively straightened shape suited for insertion through the urethra of a patient and into the patient'"'"'s bladder and a retention shape suited to retain the device within the bladder.

4. The device of claim 3, further comprising a retention frame lumen and a retention frame disposed therein.

5. The device of claim 1, wherein the first wall structure comprises silicone.

6. The device of claim 1, wherein the second wall structure comprises a thermoplastic polyurethane.

7. The device of claim 1, wherein the first wall structure comprises silicone and the second wall structure comprises a thermoplastic polyurethane.

8. The device of claim 7, wherein the silicone has a Shore hardness of from 50A to 70A.

9. The device of claim 1, wherein the first and second wall structures are formed together in a coextrusion process.

10. The device of claim 1, wherein the drug is in the form of one or more solid drug units.

11. The device of claim 1, wherein the second wall structure, or both the first and second wall structures, are water permeable, such that the device is configured to release solubilized drug by diffusion through the second wall structure upon the one or more solid drug units being contacted by water that enters the drug reservoir lumen through the second wall structure or through both the first and second wall structures.

12. A device for intravesical insertion and controlled release of a drug into the urinary bladder of a patient, the device comprising:

a housing which comprises a first wall structure and a second wall structure which are adjacent one another and together form a cylindrical tube, wherein the first and second wall structures extend between opposed ends of the cylindrical tube and bound a closed drug reservoir lumen; and

a drug in a solid or semisolid form contained in the drug reservoir lumen,

wherein;

the first wall structure is impermeable to the drug,

the second wall structure is permeable to the drug, and

the cylindrical tube is elastically deformable between a relatively straightened shape suited for insertion of the device through the urethra of the patient and into the bladder and a retention shape suited to retain the device within the bladder.

13. The device of claim 12, further comprising a retention frame lumen and a retention frame disposed therein.

14. The device of claim 12, further comprising end plugs sealing the ends of the cylindrical tube, wherein the only path for release of the drug is by diffusion through the second wall structure.

15. The device of claim 12, wherein the drug is in the form of a plurality of solid drug units.

16. The device of claim 15, wherein the second wall structure, or both the first and second wall structures, are water permeable, such that the device is configured to release solubilized drug by diffusion through the second wall structure upon the solid drug units being contacted by water that enters the drug reservoir lumen through the second wall structure or through both the first and second wall structures.

17. A method of providing controlled release of drug to a patient, comprising:

deploying a drug delivery device in the patient, the device comprising a closed drug reservoir lumen bounded by a first wall structure and a hydrophilic second wall structure; and

releasing a drug from the drug reservoir lumen via diffusion through the second wall structure,

wherein the first wall structure is impermeable to the drug, and the second wall structure is permeable to the drug, and

wherein the first wall structure and the second wall structure are adjacent one another and together form a cylindrical tube.

18. The method of claim 17, wherein implanting the drug delivery device in the patient comprises inserting the device into a body cavity or lumen of the patient through a deployment instrument.

19. The method of claim 18, wherein deploying the drug delivery device in the patient comprises:

elastically deforming the device into a relatively straightened shape;

inserting the device through the patient'"'"'s urethra; and

releasing the device into the patient'"'"'s bladder such that it deforms into a retention shape suited to retain the device within the bladder.

20. The method of claim 19, wherein the device is configured to be free floating in a patient'"'"'s bladder upon implantation.

21. A drug delivery device comprising:

a housing having a closed drug reservoir lumen bounded by a first wall structure and a hydrophilic second wall structure, wherein the first and second wall structures comprise coextruded thermoplastic polymers; and

a drug contained in the drug reservoir lumen,

wherein the first wall structure is water permeable and impermeable to the drug, and the second wall structure is permeable to the drug, and

wherein the first wall structure and the second wall structure are adjacent one another and together form an elongated tube.